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**United      States**

**Securities      and Exchange Commission**

**Washington,      DC 20549**

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**FORM      10-QSB**
** **

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**Quarterly      Report Under Section 13 or 15(d)**

**of      the Securities Exchange Act of 1934**

| **For                the quarterly period                ended**** ****September 30,                2005** | **Commission                file                number**** ****0-15070** |
|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|

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**REGENERX      BIOPHARMACEUTICALS,      INC.**

**(Exact      name of small business issuer as specified in its charter)**

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| **Delaware**                                          | **52-1253406**                                |
|-------------------------------------------------------|-----------------------------------------------|
| **(State                of Incorporation)**** ** | **(IRS                Employer I.D. Number)** |

**3      Bethesda Metro Center**

**Suite      630**

**Bethesda,      Maryland 20814**

**(Address      of principal executive offices)**

**Issuer's      telephone number, including area code**
**:      **
**(301)      280-1992**

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** **

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**RegeneRx      Biopharmaceuticals, Inc.**

**Form      10-QSB**

**Quarterly      Period Ended September 30, 2005**

**Index**

| Part                I.   Financial                Information | Page                  No.    |
|------------------------------------------------------------------------------|------------------------------|
|                                                                         |                         |   |   |
|                                                                         | Item                1.  | Financial                Statements |   |
|                                                                         |                         |   |   |
|                                                                         |                         | Balance                Sheets at September 30, 2005 (unaudited) and                December 31, 2004 | 3 |
|                                                                         |                         |   |   |
|                                                                         |                              | Statements                  of Operations for the three and nine                  months ended September 30, 2005 and 2004                  (unaudited) | 4 |
|                                                                         |                         |   |   |
|                                                                         |                              | Statements                  of Cash Flows for nine months                  ended September 30, 2005 and 2004                  (unaudited) | 5 |
|                                                                         |                         |   |   |
|                                                                         |                              | Notes                  to Financial Statements                  (unaudited) | 6 |
|                                                                         |                         |   |   |
|                                                                         | Item                2.  | Plan                  of Operation | 9 |
|                                                                         |                         |   |   |
|                                                                         | Item                3.  | Controls                and Procedures | 17 |
|                                                                         |                         |   |   |
| Part                II.   Other                Information    |                         |
|                                                                         |                         |   |   |
|                                                                         | Item                1.  | Legal                Proceedings | 17 |
|                                                                         |                         |   |   |
|                                                                         | Item                2.       | Unregistered                Sales of Equity Securities and Use                of Proceeds | 17 |
|                                                                         |                         |   |   |
|                                                                         | Item                3.       | Defaults                Upon Senior Securities | 18 |
|                                                                         |                         |   |   |
|                                                                         | Item                4.       | Submission                of Matters to a Vote of Security                Holders | 18 |
|                                                                         |                         |   |   |
|                                                                         | Item                5.       | Other                Information | 18 |
|                                                                         |                         |   |   |
|                                                                         | Item                6.       | Exhibits | 18 |
|                                                                         |                         |   |   |
| Signatures                                                                   |                         |   | 21 |

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Table      of Contents

**Part      I – Financial      Information **

**Item      1. Financial Statements**

**RegeneRx        Biopharmaceuticals, Inc.**

**Balance          Sheets**

|                                                                                                                                      |       | **September                      30,****2005** | ** **  | **December                      31,****2004** | ** ** |
|-------------------------------------------------------------------------------------------------------------------------------------------|------------|------------------------------------------------|-------------|-----------------------------------------------|------------|
| ** **                                                                                                                                | ** ** | **(unaudited)**                                |        |                                          |       |
| **ASSETS**                                                                                                                                |       |                                           |        |                                          |       |
|                                                                                                                                      |       |                                           |        |                                          |       |
| Current                      assets                                                                                                       |       |                                           |        |                                          |       |
| Cash                      and cash equivalents                                                                                            |       | $                                              | 4,127,979   |                                          | $          | 2,874,260 |   |
| Short-term                      investments                                                                                               |       |                                           | 4,746,950   |                                          |       | — |   |
| Due                      from related party                                                                                               |       |                                           | 5,591       |                                          |       | 12,357 |   |
| Deferred                      offering costs                                                                                              |       |                                           | —     |                                          |       | 75,884 |   |
| Other                      current assets                                                                                                 |       |                                           | 122,888     |                                          |       | 30,338 |   |
|                                                                                                                                      |       |                                           |        |                                          |       |   |   |
| Total                      current assets                                                                                                 |       |                                           | 9,003,408   |                                          |       | 2,992,839 |   |
|                                                                                                                                      |       |                                           |        |                                          |       |   |   |
| Fixed                      assets, net                                                                                                    |       |                                           | 56,326      |                                          |       | 2,587 |   |
| Deferred                      patent costs, net                                                                                           |       |                                           | 597,043     |                                          |       | 293,075 |   |
| Other                      assets, net                                                                                                    |       |                                           | 17,078      |                                          |       | — |   |
|                                                                                                                                      |       |                                           |        |                                          |       |   |   |
| Total                      assets                                                                                                         |       | $                                              | 9,673,855   |                                          | $          | 3,288,501 |   |
|                                                                                                                                      |       |                                           |        |                                          |       |   |   |
| **LIABILITIES                      AND STOCKHOLDERS' EQUITY**                                                                             |       |                                           |        |                                          |       |   |   |
|                                                                                                                                      |       |                                           |        |                                          |       |   |   |
| Current                      liabilities                                                                                                  |       |                                           |        |                                          |       |   |   |
| Accounts                      payable                                                                                                     |       | $                                              | 186,001     |                                          | $          | 405,997 |   |
| Accrued                      expenses                                                                                                     |       |                                           | 347,598     |                                          |       | 173,925 |   |
|                                                                                                                                      |       |                                           |        |                                          |       |   |   |
| Total                      current liabilities                                                                                            |       |                                           | 533,599     |                                          |       | 579,922 |   |
|                                                                                                                                      |       |                                           |        |                                          |       |   |   |
| Commitments                                                                                                                               |       |                                           | —     |                                          |       | — |   |
|                                                                                                                                      |       |                                           |        |                                          |       |   |   |
| Stockholders'                      equity                                                                                                 |       |                                           |        |                                          |       |   |   |
| Preferred                      stock, $.001 par value per share,                                                                          |       |                                           |        |                                          |       |   |   |
| 1,000,000                      authorized; no shares issued                                                                               |       |                                           | —     |                                          |       | — |   |
| Common                      stock, par value $.001 per share,                                                                             |       |                                           |        |                                          |       |   |   |
| 100,000,000                      shares authorized; 37,624,024 and 34,577,356                                                             |       |                                           |        |                                          |       |   |   |
| issued                      and outstanding, respectively                                                                                 |       |                                           | 37,624      |                                          |       | 34,577 |   |
| Additional                      paid-in capital                                                                                           |       |                                           | 54,867,262  |                                          |       | 45,179,591 |   |
| Accumulated                      other comprehensive income                                                                               |       |                                           | 2,159       |                                          |       | — |   |
| Accumulated                      deficit                                                                                                  |       |                                           | (45,766,789 | )                                             |       | (42,505,589 | ) |
|                                                                                                                                      |       |                                           |        |                                          |       |   |   |
| Total                      stockholders’ equity                                                                                     |       |                                           | 9,140,256   |                                          |       | 2,708,579 |   |
|                                                                                                                                      |       |                                           |        |                                          |       |   |   |
| Total                      liabilities and stockholders' equity                                                                           |       | $                                              | 9,673,855   |                                          | $          | 3,288,501 |   |
|                                                                                                                                      |       |                                           |        |                                          |       |   |   |
| The                      accompanying notes are an integral part of                      these financial                      statements. |

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Table of Contents

**RegeneRx        Biopharmaceuticals,        Inc.**

**Statements        of Operations**

|                                                                                                             |       | **Three-months                    ended****September                    30,** | ** ** | **Nine-months                    ended****September                    30,** | ** ** |
|------------------------------------------------------------------------------------------------------------------|------------|-------------------------------------------------------------------------------|------------|------------------------------------------------------------------------------|------------|
| ** **                                                                                                       | ** ** | **2005**                                                                      | ** ** | **2004**                                                                     | ** ** | **2005** | ** ** | **2004** |   |
|                                                                                                             |       |                                                                          |       |                                                                         |       |   |   |   |   |
| Revenues                                                                                                         |       | $                                                                             | —    |                                                                         | $          | — |   | $ | — |   | $ | — |   |
|                                                                                                             |       |                                                                          |       |                                                                         |       |   |   |   |   |   |   |   |   |
| Expenses                                                                                                         |       |                                                                          |       |                                                                         |       |   |   |   |   |   |   |   |   |
| Research                    and development                                                                      |       |                                                                          | 1,138,891  |                                                                         |       | 686,026 |   |   | 2,190,406 |   |   | 1,661,973 |   |
| General                    and administrative                                                                    |       |                                                                          | 316,559    |                                                                         |       | 297,585 |   |   | 1,202,704 |   |   | 848,951 |   |
|                                                                                                             |       |                                                                          |       |                                                                         |       |   |   |   |   |   |   |   |   |
| Total                    expenses                                                                                |       |                                                                          | 1,455,450  |                                                                         |       | 983,611 |   |   | 3,393,110 |   |   | 2,510,924 |   |
|                                                                                                             |       |                                                                          |       |                                                                         |       |   |   |   |   |   |   |   |   |
| Operating                    loss                                                                                |       |                                                                          | (1,455,450 | )                                                                            |       | (983,611 | ) |   | (3,393,110 | ) |   | (2,510,924 | ) |
|                                                                                                             |       |                                                                          |       |                                                                         |       |   |   |   |   |   |   |   |   |
| Other                    income (expense)                                                                        |       |                                                                          |       |                                                                         |       |   |   |   |   |   |   |   |   |
| Interest                    income                                                                               |       |                                                                          | 76,023     |                                                                         |       | 3,581 |   |   | 131,910 |   |   | 10,026 |   |
| Other                    expense                                                                                 |       |                                                                          | —    |                                                                         |       | — |   |   | — |   |   | (36 | ) |
|                                                                                                             |       |                                                                          |       |                                                                         |       |   |   |   |   |   |   |   |   |
| Total                    other income                                                                            |       |                                                                          | 76,023     |                                                                         |       | 3,581 |   |   | 131,910 |   |   | 9,990 |   |
|                                                                                                             |       |                                                                          |       |                                                                         |       |   |   |   |   |   |   |   |   |
| Net                    loss                                                                                      |       | $                                                                             | (1,379,427 | )                                                                            | $          | (980,030 | ) | $ | (3,261,200 | ) | $ | (2,500,934 | ) |
|                                                                                                             |       |                                                                          |       |                                                                         |       |   |   |   |   |   |   |   |   |
| Basic                    and diluted net loss per common                    share                                |       | $                                                                             | (0.04      | )                                                                            | $          | (0.03 | ) | $ | (0.09 | ) | $ | (0.08 | ) |
|                                                                                                             |       |                                                                          |       |                                                                         |       |   |   |   |   |   |   |   |   |
| Weighted                    average numberof                    common shares outstanding                        |       |                                                                          | 37,610,328 |                                                                         |       | 32,959,593 |   |   | 36,579,092 |   |   | 32,739,666 |   |
|                                                                                                             |       |                                                                          |       |                                                                         |       |   |   |   |   |   |   |   |   |
| The                    accompanying notes are an integral part of these financial                    statements. |

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**RegeneRx          Biopharmaceuticals,          Inc.**

**Statements of Cash Flows**

|                                                                                                                 |       | **Nine-months                      ended****September                      30,** | ** ** |
|----------------------------------------------------------------------------------------------------------------------|------------|----------------------------------------------------------------------------------|------------|
| ** **                                                                                                           | ** ** | **2005**                                                                         | ** ** | **2004** |   |
| Cash                      flows from operating activities:                                                           |       |                                                                             |       |   |   |
| Net                      loss                                                                                        |       | $                                                                                | (3,261,200 | ) | $ | (2,500,934 | ) |
|                                                                                                                 |       |                                                                             |       |   |   |   |   |
| Adjustments                      to reconcile net loss to net                                                        |       |                                                                             |       |   |   |   |   |
| cash                      used in operating activities:                                                              |       |                                                                             |       |   |   |   |   |
| Depreciation                      and amortization                                                                   |       |                                                                             | 11,906     |   |   | 3,143 |   |
| Compensation                      expense for stock options                                                          |       |                                                                             | 158,104    |   |   | 80,136 |   |
| Changes                      in operating assets and liabilities:                                                    |       |                                                                             |       |   |   |   |   |
| Other                      current assets                                                                            |       |                                                                             | (92,550    | ) |   | (88,715 | ) |
| Due                      from related party                                                                          |       |                                                                             | 6,766      |   |   | 6,323 |   |
| Other                      assets                                                                                    |       |                                                                             | (17,078    | ) |   | — |   |
| Accounts                      payable                                                                                |       |                                                                             | (241,139   | ) |   | 154,248 |   |
| Accrued                      expenses                                                                                |       |                                                                             | 249,557    |   |   | (81,040 | ) |
|                                                                                                                 |       |                                                                             |       |   |   |   |   |
| Net                      cash used in operating activities                                                           |       |                                                                             | (3,185,634 | ) |   | (2,426,839 | ) |
|                                                                                                                 |       |                                                                             |       |   |   |   |   |
| Cash                      flows from investing activities:                                                           |       |                                                                             |       |   |   |   |   |
| Purchases                      of short-term investments                                                             |       |                                                                             | (6,344,791 | ) |   | — |   |
| Maturities                      of short-term investments                                                            |       |                                                                             | 1,600,000  |   |   | — |   |
| Purchase                      of fixed assets                                                                        |       |                                                                             | (62,936    | ) |   | (1,598 | ) |
| Patents                      costs                                                                                   |       |                                                                             | (306,676   | ) |   | (170,539 | ) |
|                                                                                                                 |       |                                                                             |       |   |   |   |   |
| Net                      cash used in investing activities                                                           |       |                                                                             | (5,114,403 | ) |   | (172,137 | ) |
|                                                                                                                 |       |                                                                             |       |   |   |   |   |
| Cash                      flows from financing activities:                                                           |       |                                                                             |       |   |   |   |   |
| Issuance                      of common stock                                                                        |       |                                                                             | 9,616,499  |   |   | 2,287,003 |   |
| Proceeds                      from exercise of warrants                                                              |       |                                                                             | 6,500      |   |   | 1,500,000 |   |
| Proceeds                      from exercise of options                                                               |       |                                                                             | 6,650      |   |   | — |   |
| Stock                      Offering Costs                                                                            |       |                                                                             | (75,893    | ) |   | — |   |
|                                                                                                                 |       |                                                                             |       |   |   |   |   |
| Net                      cash provided by financing activities                                                       |       |                                                                             | 9,553,756  |   |   | 3,787,003 |   |
|                                                                                                                 |       |                                                                             |       |   |   |   |   |
| Net                      increase in cash and cash equivalents                                                       |       |                                                                             | 1,253,719  |   |   | 1,188,027 |   |
|                                                                                                                 |       |                                                                             |       |   |   |   |   |
| Cash                      and cash equivalents, at beginning of period                                               |       |                                                                             | 2,874,260  |   |   | 1,019,889 |   |
|                                                                                                                 |       |                                                                             |       |   |   |   |   |
| Cash                      and cash equivalents, at end of period                                                     |       | $                                                                                | 4,127,979  |   | $ | 2,207,916 |   |
|                                                                                                                 |       |                                                                             |       |   |   |   |   |
| The                      accompanying notes are an integral part of these financial                      statements. |

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**RegeneRx      Biopharmaceuticals, Inc.**

**Notes      to Financial Statements**

**For      the nine-months ended September 30, 2005 and 2004      (Unaudited)**

|                                                                                                                 |   | **September                  30,** |      |
|----------------------------------------------------------------------------------------------------------------------|--------|------------------------------------|-----------|
|                                                                                                                 |   | **2005**                           |      | **2004** |   |
|                                                                                                                 |   |                               |      |   |   |
| Outstanding                  stock options                                                                           |   |                               | 2,475,000 |   |   | 1,590,000 |   |
| Warrants                                                                                                             |   |                               | 1,546,815 |   |   | 1,250,881 |   |
| Total                  potential common shares excluded from diluted net loss per share                  computation |   |                               | 4,021,815 |   |   | 2,840,881 |   |

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Table        of Contents

|                                                                                                                                                          |   | **Three                  Months Ended****September                  30,** |       | **Nine                  Months Ended****September                  30,** |   |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|---------------------------------------------------------------------------|------------|--------------------------------------------------------------------------|--------|
|                                                                                                                                                          |   | **2005**                                                                  |       | **2004**                                                                 |   | **2005** |   | **2004** |   |
| Pro                  forma net loss:                                                                                                                          |   |                                                                      |       |                                                                     |   |   |   |   |   |
| As                  reported                                                                                                                                  |   | $                                                                         | (1,379,427 | )                                                                        | $      | (980,030 | ) | $ | (3,261,200 | ) | $ | (2,500,934 | ) |
| Total                  employee non-cash stock compensation expense determined under fair                  value                  based method for all awards |   |                                                                      | (107,790   | )                                                                        |   | (24,493 | ) |   | (216,639 | ) |   | (74,200 | ) |
| Pro                  forma net loss                                                                                                                           |   | $                                                                         | (1,487,217 | )                                                                        | $      | (1,004,523 | ) | $ | (3,477,839 | ) | $ | (2,575,134 | ) |
|                                                                                                                                                          |   |                                                                      |       |                                                                     |   |   |   |   |   |   |   |   |   |
| Net                  loss per common share:                                                                                                                   |   |                                                                      |       |                                                                     |   |   |   |   |   |   |   |   |   |
| Basic                  and diluted — as reported                                                                                                        |   | $                                                                         | (0.04      | )                                                                        | $      | (0.03 | ) | $ | (0.09 | ) | $ | (0.08 | ) |
| Basic                  and diluted — pro forma                                                                                                          |   | $                                                                         | (0.04      | )                                                                        | $      | (0.03 | ) | $ | (0.10 | ) | $ | (0.08 | ) |

|                                      |   | **2005** | ** **                                          | **2004** |   |
|-------------------------------------------|--------|----------|-----------------------------------------------------|----------|--------|
|                                      |   |     |                                                |     |   |
| Risk                  free rate of return |   |     | 4.30%                                               |     |   | 2.67% |   |
|                                      |   |     |                                                |     |   |   |   |
| Expected                  life (in years) |   |     | 6.00                  –                  6.75 |     |   | 5.00 |   |
|                                      |   |     |                                                |     |   |   |   |
| Volatility                                |   |     | 400                  – 450%                   |     |   | 47% |   |

*Share-Based        Payment*

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|                             |   | **Amortized                  cost** |      | **Net                  unrealized gains** |   | **Net                  unrealized losses** |   | **Estimated                  fair value** |    |
|----------------------------------|--------|-------------------------------------|-----------|-------------------------------------------|--------|--------------------------------------------|--------|-------------------------------------------|---------|
|                             |   |                                |      |                                      |   |                                       |   |                                      |    |
| Corporate                  notes |   | $                                   | 4,044,791 |                                      | $      | 3,007                                      |   | $                                         | (848    | ) | $ | 4,046,950 |   |
| Municipal                  bonds |   |                                | 700,000   |                                      |   | —                                    |   |                                      | — |   |   | 700,000 |   |
| Total                            |   | $                                   | 4,744,791 |                                      | $      | 3,007                                      |   | $                                         | (848    | ) | $ | 4,746,950 |   |

|                                                 |   | **Three                  Months Ended****September                  30,** |       | **Nine                  Months Ended****September                  30,** |   |
|------------------------------------------------------|--------|---------------------------------------------------------------------------|------------|--------------------------------------------------------------------------|--------|
|                                                 |   | **2005**                                                                  |       | **2004**                                                                 |   | **2005** |   | **2004** |   |
| Net                  loss                            |   | $                                                                         | (1,379,427 | )                                                                        | $      | (980,030 | ) | $ | (3,261,200 | ) | $ | (2,500,934 | ) |
| Unrealized                  gain on investments, net |   |                                                                      | 2,159      |                                                                     |   | — |   |   | 2,159 |   |   | — |   |
| Comprehensive                  loss                  |   | $                                                                         | (1,377,268 | )                                                                        | $      | (980,030 | ) | $ | (3,259,041 | ) | $ | (2,573,134 | ) |

*Sale        of Common Stock and Issuance of Warrants*

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*Exercise        of Warrants & Options*

**Item        2.****Plan        of Operation**

*This        report contains forward-looking statements concerning matters that involve        risks        and uncertainties. Statements made in this Item that are not purely historical,        including statements about us, our respective clinical trials, research        programs, product pipelines, current and potential corporate partnerships,        licenses and intellectual property, the adequacy of capital reserves and        anticipated operating results and cash expenditures, are forward-looking        statements within the meaning of Section 21E of the Securities Exchange Act        of        1934, as amended and Section 27A of the Securities Act of 1933, as amended.        Words such as “believes,”“likely,”“may,” and “plans” are intended to identify        forward-looking statements, although not all forward-looking statements contain        these words. These forward-looking statements concern matters that involve        risks        and uncertainties that could cause actual results to differ materially from        those projected, including risks associated with the success of research        and        product development programs, the issuance and validity of patents, the        development and protection of proprietary technologies, the ability to raise        capital, operating expense levels and the ability to establish and retain        corporate partnerships. We do not undertake any obligation to update        forward-looking statements. The following should be read in conjunction with        our        condensed financial statements included in Item 1, and the financial statements        in our Annual Report on Form 10-KSB for the year ended December 31, 2004        and in        other documents filed by us from time to time with the Securities and Exchange        Commission.*

**Overview**

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**Critical        Accounting Policies**

**Results        of operations for the three and nine months ended September 30, 2005 and        2004**

*Research        and development expenses*

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*General        and administrative expenses*

*Interest        income*

**Liquidity        and capital resources**

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**Other        factors effecting future operations**

*Investors        in RegeneRx should carefully consider the risks described below before making        an        investment decision. The risks described below may not be the only ones facing        our company. Our business could be harmed by any of these risks. The trading        price of our common stock could decline due to any of these risks, and investors        may lose all or part of their investment. In assessing these risks, investors        should also refer to the other information contained or incorporated by        reference in this Quarterly Report on Form 10-QSB and our Annual Report on        Form        10-KSB for the year ended December 31, 2004, including our financial statements        and related notes.*

*Risks        relating to our company*

*We        expect to incur losses in the future, we may not achieve or maintain        profitability, and we have no marketable products.*

*We        have limited capital resources, which may limit our planned        operations.*

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*Our        stock price is volatile, and therefore purchasers of our common stock could        incur substantial losses. *

|   | • |   | results                  of our clinical trials, and our ability to achieve regulatory approval; |
|--------|---------|--------|--------------------------------------------------------------------------------------------------|

|   | • |   | failure                  of any of our product candidates, if approved, to achieve commercial                  success; |
|--------|---------|--------|-------------------------------------------------------------------------------------------------------------------------|

|   | • |   | regulatory                  developments in the United States and foreign countries; |
|--------|---------|--------|--------------------------------------------------------------------------------------|

|   | • |   | developments                  or disputes concerning patents or other proprietary rights; |
|--------|---------|--------|-------------------------------------------------------------------------------------------|

|   | • |   | ability                  to manufacture our products to commercial standards; |
|--------|---------|--------|-------------------------------------------------------------------------------|

|   | • |   | public                  concern over our products; |
|--------|---------|--------|----------------------------------------------------|

|   | • |   | future                  litigation; |
|--------|---------|--------|-------------------------------------|

|   | • |   | the                  departure of key personnel; |
|--------|---------|--------|--------------------------------------------------|

|   | • |   | future                  sales of our common stock; |
|--------|---------|--------|----------------------------------------------------|

|   | • |   | variations                  in our financial results; |
|--------|---------|--------|-------------------------------------------------------|

|   | • |   | investors’                  perceptions of us; and |
|--------|---------|--------|----------------------------------------------------------|

|   | • |   | general                  economic, industry and market conditions. |
|--------|---------|--------|--------------------------------------------------------------------|

*We        have limited expertise with and capacity to conduct preclinical testing and        clinical trials, and our dependence on other parties could result in delays        in        and additional costs for our drug development efforts.*

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*We        depend on third parties for supply of raw materials, the loss of which could        adversely impact our clinical development program.*

*We        are exposed to product development risk and may not be able to develop a        marketable product.*

*Our        drug candidates are based *
*on        Tβ4*
*,        which must be proven effective in order for us to develop marketable products.        *

*We        rely on Dr. Goldstein, Mr. Finkelstein, and other key personnel to execute        our        business strategy. If anyone of these individuals becomes unable to perform        their responsibilities, our operations will be adversely        impacted.*

*We        are subject to competition from companies with greater resources, and may        not be        able to successfully compete.*

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*We        may be unable to obtain adequate product liability insurance, without which        we        may become exposed to potential claims.*

*We        may be unable to obtain product reimbursement by third parties, thereby        hindering our ability to generate revenue.*

*We        may take longer to complete our clinical trials than we project, or we may        not        be able to complete them at all, which could result in additional cost or        failure to commercialize our drug candidates.*

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*We        are subject to government regulation, which may hinder or prevent our ability        to        commercialize our drug candidates.*

*Risks        relating to our intellectual property*

*We        may be unable to obtain our intellectual property rights, which could erode        our        ability to establish a competitive market position.*

*We        may be unable to adequately protect or enforce our proprietary information,        which may result in its unauthorized use, a loss of revenue under a        collaboration agreement or loss of sales to generic versions of our products        or        otherwise reduce our ability to compete.*

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*If        the effective term of our patents is decreased due to changes in the United        States patent laws or if we need to refile some of our patent applications,        the        value of our patent portfolio and the revenues we derive from it may be        decreased.*

*International        patent protection is particularly uncertain and costly, and if we are involved        in opposition proceedings in foreign countries, we may have to expend        substantial sums and management resources.*

**Item        3.****Controls        and Procedures**

**Part      II - Other Information**

**Item      1.   ****Legal      Proceedings**

** **

**Item      2.   ****Unregistered      Sales of Equity Securities and Use of Proceeds**

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**Item      3.   ****Defaults      Upon Senior Securities**

**Item      4.   ****Submission      of Matters to a Vote of Security Holders**

**Item          5.   ****Other          Information**

**Item      6.   ****Exhibits**

|   | **Exhibit                  No.   ** | **Description                  of Exhibit**                                                                                                                                           | **   ** | **Reference***                                                                                                                                  |
|--------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
|   |                                               |                                                                                                                                                                                  |                   |                                                                                                                                            |
|   | 3.1                                                | Restated                  Certificate of Incorporation of the Company                                                                                                                 |         | Exhibit                  3.1 to Registration Statement No. 33-9370, Amendment No. 1 (filed                  November                  26, 1986) |
|   |                                               |                                                                                                                                                                                  |                   |                                                                                                                                            |
|   | 3.2                                                | Amendment                  to Restated Certificate of Incorporation of Company                                                                                                        |                   | Exhibit                  3.2 to the Company’s Transitional Report on Form 10-K, File No. 0-15070                  (filed March 18, 1991)  |
|   |                                               |                                                                                                                                                                                  |                   |                                                                                                                                            |
|   | 3.3                                                | Amendment                  to Restated Certificate of Incorporation of Company                                                                                                        |                   | Exhibit                  3.3 to the Company’s Form 10-KSB, File No. 0-15070 (filed April 2,                  2001)                        |
|   |                                               |                                                                                                                                                                                  |                   |                                                                                                                                            |
|   | 3.4                                                | Bylaws                  of Company                                                                                                                                                    |                   | Exhibit                  3.2 to Registration Statement No. 33-9370 (filed October 8,                  1986)                                     |
|   |                                               |                                                                                                                                                                                  |                   |                                                                                                                                            |
|   | 3.5                                                | Amendment                  No. 1 to Bylaws of Company adopted August 11, 1989                                                                                                         |                   | Exhibit                  4.7 to Registration Statement No. 33-34551, Amendment No. 3 (filed                  June                  21, 1990)    |
|   |                                               |                                                                                                                                                                                  |                   |                                                                                                                                            |
|   | 3.6                                                | Amendment                  No. 2 to Bylaws of Company adopted June 18, 1990                                                                                                           |                   | Exhibit                  4.8 to Registration Statement No. 33-34551, Amendment No. 3 (filed                  June                  21, 1990)    |
|   |                                               |                                                                                                                                                                                  |                   |                                                                                                                                            |
|   | 3.7                                                | Amendment                  No. 3 to Bylaws of Company adopted November 30, 1990                                                                                                       |                   | Exhibit                  3.6 to the Company’s Transitional Report on Form 10-K, File No. 0-15070                  (filed March 18, 1991)  |
|   |                                               |                                                                                                                                                                                  |                   |                                                                                                                                            |
|   | 4.1                                                | Form                  of Stock Certificate                                                                                                                                            |                   | Exhibit                  4.1 to Registration Statement No. 33-9370, Amendment No. 1 (filed                  November                  26, 1986) |
|   |                                               |                                                                                                                                                                                  |                   |                                                                                                                                            |
|   | 4.2                                                | Rights                  Agreement, dated as of April 29, 1994, between the Company and                  American                  Stock Transfer & Trust Company, as Rights Agent |                   | Exhibit                  1 to the Company’s Current Report on Form 8-K, File No. 0-15070 (filed May                  2, 1994)             |

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|   | **Exhibit                  No.   ** | **Description                    of Exhibit**                                                                                                         |     | **Reference***                                                                                                                                                                                 |
|--------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 4.3                                                | Warrant                    Agreement, dated March 12, 1997                                                                                            |               | Exhibit                    4.3 to the Company’s Annual Report on Form 10-K, File No. 0-15070 (filed                    March 31, 1997)                                                   |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 4.4                                                | Warrant                    Agreement, dated January 23, 2004                                                                                          |               | Exhibit                    4 to the Company’s Registration Statement on Form SB-2, File No.                    333-113417 (filed March 9, 2004)                                          |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 10.1                                               | Patent                    License Agreement - Exclusive, between the U.S. Public Health                    Service and                    the Company |               | Exhibit                    10.1 to the Company’s Form 10-KSB, File No. 0-15070 (filed April 2,                    2001)**                                                                |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 10.2                                               | Amended                    and Restated Directors Stock Option Plan                                                                                   |               | Exhibit                    10.25 to the Company’s Annual Report on Form 10-K, File No. 0-15070 (filed                    March 26, 1993)                                                 |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 10.3                                               | Amended                    and Restated 2000 Stock Option and Incentive Plan                                                                          |               | Filed                    as Exhibit A to the Company’s definitive proxy materials, File No. 0-15070                    (filed May 20, 2002)                                              |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 10.4                                               | Unit                    Purchase Agreement dated March 12, 1997                                                                                       |               | Exhibit                    10.25 to the Company’s Annual Report on Form 10-K, File No. 0-15070 (filed                    March 31, 1997)                                                 |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 10.5                                               | Registration                    Rights Agreement, dated March 12, 1997                                                                                |               | Exhibit                    10.26 to the Company’s Annual Report of Form 10-K, File No. 0-15070 (filed                    March 31, 1997)                                                 |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 10.6                                               | Lease                    Agreement dated April 5, 2002 between the Company and HQ Global                    Workplaces, Inc.                          |               | Exhibit                    10.7 to the Company’s Annual Report on Form 10-KSB, File No. 0-15070                    (filed March 31, 2003)                                                |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 10.7                                               | Employment                    Agreement                                                                                                               |               | Exhibit                    10.8 to the Company’s Registration Statement on Form SB-2, File No.                    333-113417 (filed March 9, 2004)                                       |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 10.8                                               | Employment                    Agreement                                                                                                               |               | Exhibit                    10.9 to the Company’s Registration Statement on Form SB-2, File No.                    333-113417 (filed March 9, 2004)                                       |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 10.9                                               | License                    Agreement                                                                                                                  |               | Exhibit                    10.10 to the Company’s Registration Statement on Form SB-2, File No.                    333-113417 (filed March 9, 2004) **                                   |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 10.10                                              | Securities                    Purchase Agreement                                                                                                      |               | Exhibit                    10.11 to the Company’s Registration Statement on Form SB-2, File No.                    333-113417 (filed March 9, 2004)                                      |
|   |                                               |                                                                                                                                                  |               |                                                                                                                                                                                           |
|   | 10.11                                              | Master                    Services Agreement                                                                                                          |               | Exhibit                    10.12 to the Company’s Registration Statement on Form SB-2, Amendment No.                    1, File No. 333-113417 (filed April 23,                    2004) |

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|   | **Exhibit                  No.   **                                                                                                                                                                                                                                                                                                                                                                                                    | **Description                    of Exhibit**                                |     | **Reference***                                                                                                                                                                                    |
|--------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                         |               |                                                                                                                                                                                              |
|   | 31.1                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Certifications                    dated November 14,                    2005 |               | Certifications                    Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed                    herewith)                                                                   |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                         |               |                                                                                                                                                                                              |
|   | 31.2                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Certifications                    dated November 14,                    2005 |               | Certifications                    Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed                    herewith)                                                                   |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                         |               |                                                                                                                                                                                              |
|   | 32.1                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Certifications                    dated November 14,                    2005 |               | Certifications                    Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section                    906 of                    the Sarbanes-Oxley Act of 2002 (filed herewith) |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                         |               |                                                                                                                                                                                              |
|   | 32.2                                                                                                                                                                                                                                                                                                                                                                                                                                                  | Certifications                    dated November 14,                    2005 |               | Certifications                    Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section                    906 of                    the Sarbanes-Oxley Act of 2002 (filed herewith) |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                  |                                                                         |               |                                                                                                                                                                                              |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                  |
|   |                                                                                                                                                                                                                                                                                                                                                                                                                                                       |
|   | *Except                    where noted, the exhibits referred to in this column                    have heretofore been filed with the Securities and Exchange Commission                    as                    exhibits to the documents indicated and are hereby incorporated                    by                    reference thereto. The Registration Statements referred to are                    Registration Statements of the Company. |
|   | **Portions                    of this document have been omitted pursuant to a request for                    confidential                    treatment                                                                                                                                                                                                                                                                                               |

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**Signatures**

|                                |                                                                                               |                                                                                         |
|-------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
|                                |                                                                                               | **RegeneRx                Biopharmaceuticals, Inc.**                  (Registrant) |
|                                |                                                                                               |                                                                                         |
|                                     |                                                                                               |                                                                                              |
|                                |                                                                                               |                                                                                         |
|                                |                                                                                               |                                                                                         |
| Date:November              14, 2005 |                                                                                               | /s/              J.J. FINKELSTEIN                                                            |
|                                |                                                                                                    |
|                                | J.J.                FinkelsteinPresident                and Chief Executive                Officer |
|                                |                                                                                               |
|                                |                                                                                               |
|                                |                                                                                               |
|                                |                                                                                               |
|                                | /s/              C. NEIL LYONS                                                                     |
|                                |                                                                                                    |
|                                | C.                Neil LyonsChief                Financial Officer                                 |

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